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2026 data Public-data reference. official source

HER2-positive Breast Cancer

Open-data reference.

51 US clinical trials · 28 currently recruiting

Active & Recent Trials

RECRUITING Phase 2 5,000 participants

I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

QuantumLeap Healthcare Collaborative

NCT01042379

RECRUITING Phase 3 1,300 participants

Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer

NRG Oncology

NCT05705401

RECRUITING Phase 2 500 participants

ATEMPT 2.0: Adjuvant T-DM1 vs TH

Dana-Farber Cancer Institute

NCT04893109

RECRUITING Phase 2 375 participants

A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer

Dana-Farber Cancer Institute

NCT04569747

RECRUITING NA 260 participants

Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer

University of Miami

NCT06123988

RECRUITING Phase 1 243 participants

A Phase 1/1b Study of IAM1363 in HER2 Cancers

Iambic Therapeutics

NCT06253871

RECRUITING NA 214 participants

Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer

Brigham and Women's Hospital

NCT04030507

RECRUITING Phase 2 185 participants

Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer

Baylor Breast Care Center

NCT05020860

RECRUITING 170 participants

Study of Screening Brain MRIs in Stage IV Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

NCT05115474

RECRUITING Phase 2 165 participants

PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer

MedSIR

NCT06172127

RECRUITING Phase 2 162 participants

A Study of Surgery and Radiotherapy in People With Breast Cancer

Memorial Sloan Kettering Cancer Center

NCT07053085

RECRUITING Phase 1 162 participants

A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2

Mersana Therapeutics

NCT05514717

RECRUITING Phase 2 125 participants

A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

Jazz Pharmaceuticals

NCT07102381

RECRUITING Phase 1 124 participants

PRE-I-SPY Phase I/Ib Oncology Platform Program

QuantumLeap Healthcare Collaborative

NCT05868226

RECRUITING Phase 2 72 participants

The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer

Dana-Farber Cancer Institute

NCT06439693

RECRUITING Phase 2 63 participants

TRUDI: TDXD+Durva in HER2+/Low IBC

Filipa Lynce, MD

NCT05795101

RECRUITING Phase 2 60 participants

HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission

Memorial Sloan Kettering Cancer Center

NCT07459673

RECRUITING Phase 2 53 participants

Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab

H. Lee Moffitt Cancer Center and Research Institute

NCT05325632

RECRUITING Phase 1 42 participants

HER-2 B Cell Peptide Vaccine

Pravin T.P Kaumaya

NCT06414733

RECRUITING Phase 1 39 participants

Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease

H. Lee Moffitt Cancer Center and Research Institute

NCT04588545

RECRUITING Phase 1 36 participants

HER2 Vaccine for Locally Advanced Breast Cancer

Pravin T.P Kaumaya

NCT06949410

RECRUITING Phase 2 30 participants

Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers

Ruth O'Regan

NCT04886531

RECRUITING Early Phase 1 30 participants

Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer

Alison Stopeck

NCT06220214

RECRUITING Phase 1 28 participants

Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

NCT05378464

RECRUITING Phase 2 28 participants

BRE-10: Biomarker Optimization of Neoadjuvant Therapy in Breast Cancer

University of Illinois at Chicago

NCT06441890

RECRUITING Phase 1 25 participants

Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI

University of Alabama at Birmingham

NCT04332588

RECRUITING Phase 1 18 participants

A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV)

H. Lee Moffitt Cancer Center and Research Institute

NCT05809752

RECRUITING NA 15 participants

NearWave Optical Molecular Monitoring

Indiana University

NCT06744465

ACTIVE NOT RECRUITING Phase 3 466 participants

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

Seagen, a wholly owned subsidiary of Pfizer

NCT03975647

ACTIVE NOT RECRUITING Phase 1 275 participants

ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer

Enliven Therapeutics

NCT06328738

ACTIVE NOT RECRUITING Phase 1 210 participants

A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Solid Tumors

Hoffmann-La Roche

NCT05593094

ACTIVE NOT RECRUITING Phase 2 174 participants

MARGetuximab Or Trastuzumab (MARGOT)

Dana-Farber Cancer Institute

NCT04425018

ACTIVE NOT RECRUITING Phase 2 138 participants

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]

University of Texas Southwestern Medical Center

NCT03747120

ACTIVE NOT RECRUITING Phase 2 134 participants

Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases

Brigham and Women's Hospital

NCT04899908

ACTIVE NOT RECRUITING Phase 2 119 participants

Vaccine to Prevent Recurrence in Patients With HER-2 Positive Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

NCT03384914

ACTIVE NOT RECRUITING Phase 2 82 participants

STOP-HER2: Stopping Trastuzumab in HER2+ MBC

Dana-Farber Cancer Institute

NCT05721248

ACTIVE NOT RECRUITING Phase 2 63 participants

Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer

City of Hope Medical Center

NCT01730833

ACTIVE NOT RECRUITING Early Phase 1 31 participants

HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

NCT03387553

ACTIVE NOT RECRUITING Phase 1 24 participants

HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases

City of Hope Medical Center

NCT03696030

ACTIVE NOT RECRUITING 23 participants

Study of Cardiopulmonary Exercise Testing in Women Who Have HER2-Positive Breast Cancer With Mild Cardiotoxicity

Memorial Sloan Kettering Cancer Center

NCT05036252

ACTIVE NOT RECRUITING Phase 2 17 participants

TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer

Mayo Clinic

NCT03179904

ACTIVE NOT RECRUITING Phase 2 16 participants

Clinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer

Fox Chase Cancer Center

NCT03125928

ACTIVE NOT RECRUITING 13 participants

Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy

University of Washington

NCT03738553

ACTIVE NOT RECRUITING NA 12 participants

Omission of Radiation in Patients With Her-2 Positive Breast Cancer

University of Kansas Medical Center

NCT03460067

ACTIVE NOT RECRUITING NA 10 participants

Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer

City of Hope Medical Center

NCT02226276

ACTIVE NOT RECRUITING Phase 2 7 participants

HER2HEART-US: Prevention of Cardiotoxicity in Breast Cancer Patients Receiving HER2-directed Therapy

Washington University School of Medicine

NCT06844669

COMPLETED Phase 1 41 participants

PRS-343 in Combination With Atezolizumab in HER2-Positive Solid Tumors

Pieris Pharmaceuticals

NCT03650348

COMPLETED Phase 1 37 participants

TAEK-VAC-HerBy Vaccine for Brachyury and HER2 Expressing Cancer

Bavarian Nordic

NCT04246671

COMPLETED Phase 2 37 participants

Trastuzumab and Interleukin-2 in Treating Patients With Metastatic Breast Cancer

National Cancer Institute (NCI)

NCT00006228

COMPLETED Phase 1 30 participants

Doxorubicin Hydrochloride Liposome, Cyclophosphamide, and Trastuzumab in Treating Patients With Stage IV Breast Cancer

University of Washington

NCT00331552

COMPLETED Phase 1 23 participants

Vaccine Therapy in Treating Patients With Stage IV Breast Cancer

University of Washington

NCT00791037

Phase Distribution

PhaseTrial count
Early Phase 1 18
Phase 2 23
Phase 3 2

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the HER2-positive Breast Cancer Trial Landscape

ClinicalTrials.gov lists 51 US studies indexed under HER2-positive Breast Cancer, and 28 of those are currently open to recruitment — roughly 55% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

The phase distribution for HER2-positive Breast Cancer shows 2 late-stage studies (Phase 3 and Phase 4 combined) alongside 41 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

Top sponsor activity for HER2-positive Breast Cancer is led by H. Lee Moffitt Cancer Center and Research Institute with 7 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 51 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for HER2-positive Breast Cancer?

PlainTrial tracks 51 US clinical trials for HER2-positive Breast Cancer, of which 28 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for HER2-positive Breast Cancer?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2024 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

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